Cadence Chamfer Cut Total Ankle System

GUDID 00816847022637

A three dimensional physical model depicting patient specific anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan.

3D SYSTEMS, INC.

Custom-made organ/bone anatomy model

• Primary Device ID: 00816847022637
• NIH Device Record Key: 4193b008-fc68-4f29-b1f5-ef5e6030ff12
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cadence Chamfer Cut Total Ankle System
• Version Model Number: Anatomical model
• Company DUNS: 085049749
• Company Name: 3D SYSTEMS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816847022637 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241326

FDA Product Code

• OYK: Ankle Arthroplasty Implantation System

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00816847022637]

Moist Heat or Steam Sterilization

[00816847022637]

Moist Heat or Steam Sterilization

[00816847022637]

Moist Heat or Steam Sterilization

[00816847022637]

Moist Heat or Steam Sterilization

[00816847022637]

Moist Heat or Steam Sterilization

[00816847022637]

Moist Heat or Steam Sterilization

[00816847022637]

Moist Heat or Steam Sterilization

[00816847022637]

Moist Heat or Steam Sterilization

[00816847022637]

Moist Heat or Steam Sterilization

[00816847022637]

Moist Heat or Steam Sterilization

[00816847022637]

Moist Heat or Steam Sterilization

[00816847022637]

Moist Heat or Steam Sterilization

[00816847022637]

Moist Heat or Steam Sterilization

[00816847022637]

Moist Heat or Steam Sterilization

[00816847022637]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-09-20
• Device Publish Date: 2024-09-12

On-Brand Devices [Cadence Chamfer Cut Total Ankle System]

• 00816847022729: A physical guide that is composed of patient's bony anatomy and allows for precise location of p
• 00816847022712: A physical guide that is composed of patient's bony anatomy and allows for precise location of p
• 00816847022637: A three dimensional physical model depicting patient specific anatomy. To be used as pre- and in